July 2021 FDA Recall Gavilyte - C by Novel Laboratories, Inc. D.b.a Lupin
D-0726-2021 - Failed Stability Specification; Out of specification for Osmolarity

This Class II drug recall was voluntarily initiated by Novel Laboratories, Inc. D.b.a Lupin on July 29, 2021 for the product Gavilyte - C. The FDA reported the reason for recall as failed stability specification; out of specification for osmolarity. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0726-2021

Reason for Recall
Failed Stability Specification; Out of specification for Osmolarity
Initiated
07-29-2021
Reported
08-25-2021
Quantity
20,814 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88390
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Novel Laboratories, Inc. d.b.a LUPIN
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-14-2022
Product Description About Product Description
Full technical description of the product.
GaviLyteTM - C PEG-3350 (240g) and Electrolytes for Oral Solution, USP with Flavor Pack Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873, USA Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-060-19

Batch or Lot Expiration Information

Lot# Lot S001133, exp 7/2022

Affected Packages Involved in this Recall

43386-060-19 Gavilyte - C Tm